FDA Panel Considers Dynavax’s Heplisav Safety Database Insufficient
This article was originally published in The Pink Sheet Daily
The sponsor’s proposal for a post-approval cohort safety study in 30,000 patients failed to alleviate the concerns of a majority of the vaccines advisory committee, which voted 8 to 5 with one abstention that available data do not support the safety of the hepatitis B vaccine.
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FDA calls off November meeting to give 'more time to review and resolve several outstanding issues' with adjuvanted hepatitis B vaccine; Dynavax says agency determined meeting was not necessary to ensure regulatory decision by Dec. 15 goal date.
After clinical hold, lost partnership and rejection by an advisory committee four years ago, Dynavax will again make its case for approval of Heplisav-B.
In a “complete response” letter for the novel, adjuvanted hepatitis B vaccine, FDA cites the need for more safety data in the broad population of adults for which approval was sought; however, Dynavax says the agency appears open to considering a more restricted use, such as in patients with chronic kidney disease.